Clinical Study of VG161 in the Treatment of Advanced Bone and Soft Tissue Sarcoma

NCT06126510 | Recruiting Phase 2 DMC

• 1 other identifier: VG161-C206
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study plans to use 1.0×108PFU/day per cycle, intratumoral injection administration for 3 consecutive days, and 28 days as a cycle. Tumor imaging evaluation was performed every 8±1 weeks from the first dose of C1D1 until an event that met the criteria for treatment discontinuation occurred.

Conditions

Sarcoma

Outcome Measures

Primary Outcomes (3)

• ORR

  Objective response rate (ORR)

  through the study completion, an average of 2 year

• 4-month PFS rate

  4-month Progression Free Survival (PFS) rate

  through the study completion, an average of 2 year

• 6-month PFS rate

  6-month Progression Free Survival (PFS) rate

  through the study completion, an average of 2 year

Secondary Outcomes (7)

• DCR

  through the study completion, an average of 2 year

• PFS

  through the study completion, an average of 2 year

• OS

  through the study completion, an average of 2 year

• DOR

  through the study completion, an average of 2 year

• Immunological indicators

  through the study completion, an average of 2 year

Study Arms (1)

Experimental: Single Arm

EXPERIMENTAL

VG161:1.0 × 10 \^ 8 PFU daily for 3 consecutive days on Days 1-3 of each cycle (D1-D3)

Drug: Recombinant Human IL12/15-PDL1B Oncolytic HSV-1 Injection (Vero Cell)

Interventions

Recombinant Human IL12/15-PDL1B Oncolytic HSV-1 Injection (Vero Cell) DRUG

VG161:1.0×10\^8PFU/day, intratumoral injection administration for 3 consecutive days, 28 days as a cycle

Also known as: VG161

Experimental: Single Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must give informed consent to this study before the trial and voluntarily sign a written informed consent form.
• Age 18 to 75 years old (inclusive), gender is not limited.
• Patients with advanced bone and soft tissue sarcoma confirmed by histopathological or cytology, who are unresectable by surgery and have failed at least one standard treatment (among them, patients with Ewing sarcoma need to be patients without standard treatment).
• According to RECIST 1.1, it is determined that at least one CT examination shows measurable and meets the volume requirement for the first injection, superficial lesions are preferred, and tumor lesions that can be injected under ultrasound guidance can also be selected (the injected lesions are preferably major tumor burden lesions), and the longest diameter of the injected lesion at baseline (short diameter for lymph node lesions) \> 1.5cm.
• Those who have a positive HSV-1 IgG or HSV-1 IgM antibody test result (HSV-1 IgM).
• ECOG physical status score of 0-1.
• Estimated survival time of more than 3 months.
• Have adequate organ function:
• Blood routine (no blood transfusion or colony-stimulating factor therapy within 14 days): ANC≥1.5×109/L, PLT≥75×109/L, Hb≥85g/L, lymphocyte count≥1.5×109/L (for lymphocyte count 0.8×109/L to 1.5×109/L at the discretion of the investigator);
• Liver function: TBIL ≤1.5×ULN, ALT≤3×ULN, AST≤3×ULN (ALT≤5×ULN and AST≤5×ULN are acceptable for patients with liver metastases);
• Renal function: Cr≤1.5×ULN, and creatinine clearance ≥45ml/min (calculated according to Cockcroft-Gault formula);
• Coagulation function: activated partial thromboplastin time (APTT) ≤ 1.5×ULN, international normalized ratio (INR) ≤1.5×ULN.
• Eligible subjects (males and females) of childbearing potential must agree to use a reliable method of contraception (hormonal or barrier method or abstinence) for the duration of the trial and for at least 3 months after the last dose; Female patients of childbearing potential must have a negative blood pregnancy test within 7 days prior to enrollment.

You may not qualify if:

• Have received chemotherapy, radiotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy and other anti-tumor drugs within 4 weeks before the first use of study drugs, among which oral fluorouracils and small molecule targeted drugs are the first use of study drugs. Within the first 2 weeks or the 5 half-lives of the drug (whichever is longer).
• Have received other unmarketed clinical trial treatments within 4 weeks before using the study drug for the first time.
• Have undergone major organ surgery (excluding puncture biopsy) or experienced significant trauma within 4 weeks before taking the study drug for the first time.
• Patients who have received systemic corticosteroids (prednisone \>10 mg/day or equivalent doses of similar drugs) or other immunosuppressants within 14 days before the first use of study drugs; Exceptions are the following: treatment with topical, ocular, intraarticular, intranasal, and inhaled corticosteroids; short-term use of corticosteroids (≤10 mg prednisone equivalent) for prophylactic treatment (e.g., prevention of contrast media allergy).
• Have received vaccination within 4 weeks before the first use of study drugs.
• The adverse reactions of previous anti-tumor treatments have not returned to CTCAE 5.0 grade ≤1 (except for toxicities such as hair loss that the researcher has judged to have no safety risks).
• With spinal cord compression, the researcher determines that the patient is not suitable for enrollment.
• In the period of recurrent infection of herpes simplex virus, with corresponding clinical manifestations, such as cold sores, herpetic keratitis, herpetic dermatitis, genital herpes, etc.
• Other uncontrolled active infections.
• Have a history of immunodeficiency, including positive HIV antibody test and Treponema pallidum antibody test.
• Patients with active chronic hepatitis B or active hepatitis C (except hepatitis B virus carriers, stable hepatitis B after drug treatment \[negative HBV-DNA test or \<50IU/ml\] and cured hepatitis C patients \[HCV RNA Tested negative\]).
• Have a history of severe cardiovascular disease:
• Ventricular arrhythmias requiring clinical intervention;
• QTc interval\>480ms;
• Acute coronary syndrome, congestive heart failure, stroke or other grade III or above cardiovascular events within 6 months before using the study drug for the first time;

Sponsors & Collaborators

• CNBG-Virogin Biotech (Shanghai) Ltd.: lead

Study Sites (1)

Peking University People's Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Lu Xie, Medical PhD

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lu Xie, Medical PhD

CONTACT

13401044719; xie.lu@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2023
• First Posted: November 13, 2023
• Study Start: July 18, 2023
• Primary Completion: July 17, 2025
• Study Completion: January 17, 2026
• Last Updated: December 24, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)